BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 2197723 · Received July 27, 2011

    Report

    Report Number
    2027969-2011-01649
    Event Type
    Other
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2011, INRATIO METER: 3.2 INR, REFERENCE: 2.3 INR, MEAN: 2.75, CONFIDENCE LIMITS: 1.7-3.8. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYS INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. INVESTIGATION IS PENDING ON RETURNED METER. THE RESULTS OF THIS INVESTIGATION AND THE TRENDING INFO WILL BE SUBMITTED ON A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 3.5, LAB: 2.3. PT'S THERAPEUTIC RANGE IS 2.0-3.0. DOCTOR ADJUSTED COUMADIN BASED ON INRATIO INR=3.5 READING AND, ONCE THEY RECEIVED THE LAB READING, CHANGED THE DOSAGE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other